Steve Fulkert

Steve Fulkert, 63, of Southern Delaware County, learned in 2009 he had a slow growing form of lymphoma and managed the disease for many years.

In the winter of 2015, however, he developed a sore throat, cough and fatigue that he just couldn’t shake. When he felt lumps in his neck, he knew the cancer had probably gone from docile to actively growing.

On New Year’s Eve, he was camped out in his oncologist office and soon after was diagnosed with a different cancer — diffuse large B-cell lymphoma (DLBCL), positive for three genetic mutations that put him in category of the rarest and most aggressive form of the disease. He began chemotherapy and his oncologist recommended seeking a second opinion at the OSUCCC – James.

The director of the OSUCCC – James Blood and Bone Marrow Transplant Program suggested holding off on a stem cell transplant, noting that if he failed standard chemotherapy there was a promising new immunotherapy approach called CAR-T as a possible future treatment option.

Unfortunately, after five months of intense chemotherapy, Steve’s cancer persisted. The good news was that he now qualified for a CAR-T therapy clinical trial.

A New Immunotherapy Approach

CAR-T involves extracting and re-engineering disease-fighting white cells (T-cells) from a patient’s blood by exposing them to a de-activated virus makes them able to recognize specific markers on the surface of the DLBCL cells. These “re-educated” T-cells are then infused back into the patient, similar to an autologous stem cell transplant process.

“But instead of relying on high-dose chemotherapy to eradicate the cancer and using stem cells as a rescue to regrow healthy bone marrow cells, CAR-T therapy essentially creates ‘super T-cells’ that go in and recognize a specific marker on the surface of the cancer cell and then eradicate the cancer directly,” says Samantha Jaglowski, MD, a hematologist who leads the CAR-T immunotherapy research trials at the OSUCCC – James.

“Initial results suggest this could be a powerful and effective therapy with minimal side effects for most patients. It also allows patients to avoid major disruptions to daily life that come with immunosuppression as patients go through and recover from a stem cell transplant,” adds Jaglowski.

Initial clinical trials have focused on various subtypes of lymphoma but future trials will open soon testing for new forms of T-cell immunotherapy in solid tumors like cervical and lung cancer as well as sarcoma. In some of those trials, instead of T-cells being harvested from the patients’ blood they will be extracted from the tumor.

The Best Chance for Cure: A Clinical Trial

After evaluating all the options, Steve felt strongly that the CAR-T clinical trial was the right next step in his treatment. In late June 2016, he went through all the testing and prep to create his customized “super T-cell injection.” Then he waited three months for the injection to be prepared and sent to Columbus.

“Those three months were nerve-wrecking. The tumor was in the back of my throat so I was in a lot of pain and having trouble eating, swallowing and sleeping. I had to continue chemotherapy to keep the cancer at bay and stay well enough to get the CAR-T injection,” recalls Steve.

On October 12, he was admitted to the hospital to prepare for the CAR-T treatment, which he received Oct. 13, 2016.

“Within minutes I could feel those T-cells attacking my cancer – it was like a war zone in my throat. I could literally feel the tumor shrinking. Every day the pain got a little better and within 30 days the pain was essentially gone,” Steve recalls. “For me, the targeted T-cell treatment was easy and the side effects were trivial compared to the arduous chemotherapy treatments with their short- and long-term side effects.”

Imaging tests 90 days after the injection also showed no sign of disease.

“It is great to be back among the living. I am regaining the stamina I had before cancer, and otherwise I feel wonderful. I am thankful that my oncology team kept me well enough to complete this clinical trial, and I hope more patients are able to receive this treatment very soon,” Steve says.

The OSUCCC – James has a number of active and pending clinical trials available for patients with lymphoma. Before the end of the year, oncologists anticipate that at least one of the CAR-T cell products for lymphoma and leukemia will be approved by the Food and Drug Administration.